Clear+Brilliant Laser System

Q: What is the product code of K110349?

The FDA product code is ONG – Powered Laser Surgical Instrument With MicrobeamFractional Output, a Class II (moderate risk) device regulated under 21 CFR 878.4810.

FDA 510(k) K110349 · Solta Medical, Inc.

Substantially Equivalent

510(k) numberK110349

Submission

Device name: Clear+Brilliant Laser System
Applicant: Solta Medical, Inc.
Hayward, CA, US
Received: February 7, 2011
Decision date: May 3, 2011
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: ONG – Powered Laser Surgical Instrument With MicrobeamFractional Output
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.4810
Specialty: General, Plastic Surgery

A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. The laser output is in form of tiny beams in micro range. Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic to destroy, remove or coagulate tissue, generally soft tissue. Indication for…

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Questions and answers

When was Clear+Brilliant Laser System cleared by the FDA?

Clear+Brilliant Laser System (K110349) received a 510(k) decision of Substantially Equivalent on May 3, 2011, 85 days after the submission was received.

What is the product code of K110349?

The FDA product code is ONG – Powered Laser Surgical Instrument With MicrobeamFractional Output, a Class II (moderate risk) device regulated under 21 CFR 878.4810.